Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Housing: only one animal was tested
- Diet (e.g. ad libitum): n.a.
- Water (e.g. ad libitum): n.a.
- Acclimation period: 1 day


ENVIRONMENTAL CONDITIONS
according to guideline

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.01 mL
Duration of treatment / exposure:
no washing
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: DRAIZE score, irritation index


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72h
Score:
4
Max. score:
4
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: reading at 72 h only because of severe chemosis;
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24h -72h
Score:
3
Max. score:
3
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: hemorrhages
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24h -72h
Score:
4
Max. score:
4
Reversibility:
other: animal was killed for ethical reasons after 72 h
Remarks on result:
other: complete closure of eyelids due to severe swelling
Irritant / corrosive response data:
cornea score: reading was only at 72 h possible  because of severe chemosis
iris score: could not be evaluated because of severe chemosis
Other effects:
The animal was killed for ethical reasons at day 3. Severe damage of the eye.

Any other information on results incl. tables

animal was killed for ethical reasons after 72 h

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Classification: risk of serious damage to eyes